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Randomized Controlled Trial
Oral zinc supplementation for reducing mortality in probable neonatal sepsis: a double blind randomized placebo controlled trial.
- K Mehta, N K Bhatta, S Majhi, M K Shrivastava, and R R Singh.
- Department of Pediatrics and Adolescent Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal.
- Indian Pediatr. 2013 Apr 1; 50 (4): 390-3.
ObjectiveTo study the role of Zinc in the treatment of neonatal sepsis.DesignDouble blind, randomized, placebo controlled trial.SettingTertiary Care Hospital.Participants614 neonates with probable neonatal sepsis.InterventionThe drug group (n=307) received 1mg/kg/day of elemental zinc, and placebo group (n=307) received the placebo, in addition to antibiotic therapy and supportive care, till the final outcome (discharge/death).Outcome MeasuresDecrease in mortality rates (primary outcome), duration of hospital stay and need of higher lines of antibiotic therapy (secondary outcomes) were tested.ResultsBaseline characteristics of the two groups were similar. No statistically significant differences between drug and placebo group were found in mortality rate (9.77% vs 7.81%; P=0.393), mean duration of hospital stay (142.85 ± 69.41 hrs, vs. 147.99 ± 73.13 hrs; P=0.841), and requirement of higher lines of antibiotic therapy (13.35% vs 12.05%, P=0.628) after supplementation.ConclusionsThis study does not report decrease in mortality rates, duration of hospital stay and requirement of higher lines of antibiotic therapy following zinc supplementation in neonatal sepsis.
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